Healthcare facilities employ multiple strategies to prevent and/or reduce infections associated with the use of percutaneous and drug delivery medical devices, which are devices that are temporarily left inside the body and that protrude out of the skin and exposed to the environment, in potential contact with microbial infection. Such strategies include topical cleansing at the site of insertion, use of antimicrobial dressings to protect the insertion site, prophylactic prescription of antibiotics, and use of catheters coated with antimicrobial agents, among others. There is evidence that protecting catheter insertion sites with antimicrobial dressings impregnated with antimicrobial agents, such as chlorhexidine gluconate, reduce skin colonization, which may be correlated to a lower incidence of catheter blood stream infections.
Many types of dressings are known for the treatment of wounds and insertion sites of percutaneous and drug delivery devices. Johnson & Johnson Corporation markets a commercially available product sold under the trademark BIOPATCH® that is applied around percutaneous devices to prevent localized infection at the insertion site. This product is a foam material that contains the antimicrobial agent chlorhexidine gluconate (CHG). Efforts to coat the percutaneous and drug delivery medical devices with antimicrobial agents are also known.
Foam dressings (or pads) that protect insertion sites generally have an opening to conform around the percutaneous device. Depending on the size of the dressing and the percutaneous device, a transparent film is used to secure the dressing pad to the skin. The foam dressing and the transparent film come separately packaged, and the health care practitioner undertakes a two step process to dress the wound. First, the practitioner must open the package with the foam pad and apply it to the insertion site, and then the practitioner must open the package of the transparent dressing, remove the backing paper, and apply the transparent dressing over the foam dressing, all while keeping the insertion site clean and the patient potentially moving.
Transparent film dressings that allow a visual check on a catheter insertion site have recently been used as described in U.S. Pat. No. 5,372,589, issued Dec. 13, 1994 to Davis. Centurion Medical Products markets a commercially available catheter site dressing sold under the trademark SorbaView® SHIELD. It was recognized that a one-step dressing for catheters would be very practical for dressing catheters. 3M Corporation markets a commercially available intravenous (IV) site transparent dressing sold under the trademark TEGADERM™-CHG (clorhexidine gluconate) that is claimed to reduce the incidence of catheter-related bloodstream infections (CRBSI), with the CHG being the antimicrobial agent. The CHG is embedded in a hydrogel pad. The gel pad does not have a slit to go around the device, so it can only be laid on top of the catheter. Thus, the device fails to provide 360 degree or complete circumferential coverage around the insertion site.
U.S. Pat. No. 5,833,665, issued Nov. 10, 1998 to Bootman, et al., is directed to a particular composition of a foam pad and shows a release profile of antimicrobial agent. This patent discloses a pad that is fully integrated or affixed to a top adhesive layer; both the pad and the adhesive layer are adapted with a slit. Positioning of this device over the insertion site of an indwelling catheter on a patient requires manipulation of the top layer and the pad, which could lead to catheter dislodgement or pistoning (moving back and forth), which might introduce bacteria into the bloodstream.
There is a need to provide an antimicrobial absorbent pad integrated with a transparent dressing, first to provide 360 degree protection of the catheter insertion site and for securing such pad, with an easy mechanism for deploying.